ATTUNE 1516-30-908Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295048251), received between Dec 2, 2019 and Oct 15, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION INSTABILITY DUE TO A PCL RUPTURE. SURGEON REVISED INSERT TO THICKER AND WAS ABLE TO ACHIEVE STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 20451062 ↗
• MalfunctionFeb 27, 2020Expiration Date Error; Expiration Date Error

  SURGEON INFORMED THE SALES REP THAT AN ATTUNE POLYETHYLENE BEARING COMPONENT WAS IMPLANTED IN A PATIENT AND THE EXPIRY DATE ON THE BOX WAS NOVEMBER 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764739 ↗
• InjuryDec 2, 2019Naturally Worn; Naturally Worn

  REVISION DUE TO POLY WEAR. DOI: (B)(6) 2017, DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9395380 ↗